Methods and systems for in situ tissue marking and orientation stabilization

ABSTRACT

A method of marking an orientation of a cut specimen of tissue prior to excision thereof from a body includes steps of disposing a tissue-marking probe in the body adjacent the cut specimen, the tissue-marking probe including a tissue-marking tool configured to selectively mark the cut specimen. A surface of the cut specimen is then marked with the tissue-marking tool such that the orientation of the cut specimen within the body is discernable after the cut specimen is excised from the body. The tissue-marking tool may be configured to selectively bow out of and back into a window defined near a distal tip of the probe and the marking step may include a step of selectively bowing the tissue-marking tool out of the window and following the surface of the cut specimen while rotating the probe. The tissue-marking tool may include an RF cutting tool and the marking step may include a step of coagulating or cauterizing a selected portion of the surface of the cut specimen with the RF cutting tool. Alternatively, the marking step may include a step of delivering dye onto selected portions of the surface of the cut specimen.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to the marking of soft tissue specimens topreserve or reconstruct the orientation of a soft tissue specimen afterthe specimen is removed from the patient's body.

2. Description of the Related Art

The marking of a biopsy specimen to indicate the orientation of thespecimen within the body may be crucial for later treatment. Forexample, knowledge of the exact orientation of a biopsy specimen ofbreast tissue is an important aspect of any breast conserving therapyfor breast cancer. A proper biopsy should have good margins of normal,uninvolved breast tissue surrounding the cancerous lesion within thebreast. If a margin is “dirty” (close to or involved with the lesion),the risk of recurrence of the cancer increases. What distance actuallyconstitutes a good margin remains controversial. Large margins aresafest, but may result in an overly large cavity within the breast,which may result in a less than satisfactory cosmetic result. Smallermargins, on the other hand, result in smaller cavities within thebreast, but increase the risk that some of the cells on the periphery ofthe margin will be found to be involved in the lesion. Moreover, smallermargins may increase the risk of seeding cancerous cells within thebreast. For example, 1 cm margins are universally accepted as safe,while some favor the excision of specimens with margins of as little as1 mm. The National Surgical Adjuvant Breast and Bowel Project (NSABP),the major study group for breast treatment, has previously endorsed amargin equal to one normal cell between the cancer and the cut edge ofthe specimen. The mainstream approach, however, appears to call for 5 mmto 10 mm margins between the cancerous lesion and the cut edge of thespecimen. Except for some women with Ductal Carcinoma In Situ (DCIS),women who undergo biopsies with such margins will also receivepost-operative radiation therapy to treat any remaining cancer withinthe breast.

Best practices indicate that the biopsy specimen should be marked afterremoval thereof form the patient, in case one or more cut surfacescontain tumor or are close to the tumor. If the surgeon learns from thepathologist that the inferior margin is “positive”, the he or she willtake the patient back to the operating room and excise additional tissuefrom the inferior aspect of the cavity. If the specimen is notadequately marked, then tissue from the entire cavity must be excised.This may lead to the unnecessary excision of a vast amount of normalbreast tissue, leading to an unsatisfactory cosmetic result. For atleast these reasons, specimen marking for orientation is essential andshould be an integral part of any breast (or any other soft tissue)cancer treatment protocol.

Many surgeons mark the excised specimen by sewing a suture ontodifferent sides of the specimen (usually two or three sides). An exampleof such marking would be a short suture to mark the superior aspect ofthe specimen, a long suture to mark the lateral aspect thereof and asuture with short and long tails to mark the deep aspect of thespecimen. If the surgeon determines that a radiograph or an X-ray isneeded to confirm that the excised specimen contains suspiciousmicrocalcifications, the specimen may be sent to a radiology departmentbefore the pathologist receives the specimen. The specimen is thentypically flattened between two parallel plates to take the radiograph.This completely distorts the specimen, and it will never return to itsoriginal shape. This distortion renders the reconstruction of thespecimen orientation difficult. For example, after a flattened specimenis returned to the surgeon, the sutures for the superior and lateralaspects may appear on the same side of the specimen.

A second and better way to mark specimens is to mark each side of theexcised specimen (6 sides total) with a different color of stain. Inthis manner, if the specimen is distorted following a radiograph, thecolored stain will still dictate the original orientation of the excisedspecimen within the surrounding tissue.

When a tissue specimen is removed from the breast, it should be removedwithout disturbing its original orientation within the breast. However,during the actual excision when the specimen is still within the breast,it may twist and/or turn, which changes its orientation even before itis removed. Thus, marking a specimen after removing it from the patientmay not preserve the original orientation of the specimen. Therefore,even conscientious marking of an excised specimen may not preserve thetrue orientation of the lesion within the surrounding tissue. In turn,such marking may lead to confusion, misinformation and ultimately mayresult in a less than optimal treatment of the patient.

What are needed, therefore, are improved methods and systems for tissuemarking. What are also needed are methods, systems and devices forpreserving the orientation of tissue specimens.

SUMMARY OF THE INVENTION

It is, therefore, an object of the present invention to provide methodsand systems for tissue marking. It is another object of the presentinvention to provide methods, systems and devices for preserving theorientation of tissue specimens.

In accordance with the above-described objects and those that will bementioned and will become apparent below, a method of marking anorientation of a cut specimen of tissue prior to excision thereof from abody, includes steps of disposing a tissue-marking probe in the bodyadjacent the cut specimen, the tissue-marking probe including atissue-marking tool configured to selectively mark the cut specimen andmarking a surface of the cut specimen with the tissue-marking tool suchthat the orientation of the cut specimen within the body is discernableafter the cut specimen is excised from the body.

The tissue-marking tool may be configured to selectively bow out of andback into a window defined near a distal tip of the probe and themarking step may include a step of selectively bowing the tissue-markingtool out of the window and following the surface of the cut specimenwhile rotating the probe. The disposing step may dispose thetissue-marking probe directly within the tissue. The disposing step maydispose the tissue-marking probe within a cannula disposed adjacent thecut specimen. The tissue-marking tool may include an RF cutting tool andthe marking step may include a step of coagulating a portion of thesurface of the cut specimen with the RF cutting tool. The coagulatingstep may include a step of momentarily increasing an RF power deliveredto the portion of the surface of the cut specimen by the RF cuttingtool. Alternatively, the coagulating step may include a step ofmomentarily maintaining the RF cutting tool substantially immobile onthe portion of the surface of the specimen while the RF power deliveredto the RF cutting tool is maintained constant.

The marking step may include a step of delivering dye onto the surfaceof the cut specimen. The dye may include, for example, Methylene Blue,Congo Red and/or Lymphazurin® Blue. The marking step may includedelivering a first dye of a first color to a first portion of thesurface of the cut specimen and delivering a second dye of a secondcolor to a second portion of the surface of the cut specimen. The firstportion may include a proximal and/or a distal end of the cut specimen.The dye-delivering step may deliver the dye at a selectable graduatedrate to the surface of the specimen. In this manner, the dye may bedelivered darker to a first portion of the surface of the specimen andmay be delivered relatively lighter to a second portion of the surfaceof the specimen.

The present invention is also a soft tissue excisional method,comprising the steps of disposing a probe within tissue from which atissue specimen may be to be taken, the probe including an RF tissuecutting tool configured to selectively bow out of and back into a windowdefined near a distal tip of the probe; rotating the probe whileapplying RF energy to the RF cutting tool and selectively bowing thecutting tool out of the window to cut the specimen from the tissue andselectively coagulating selected portions of a surface of the specimenwith the RF cutting tool such by that the orientation of the specimenwithin the body may be discernable after the cut specimen may be excisedfrom the body.

The method may further include a step of isolating the cut specimen fromsurrounding tissue by at least partially encapsulating the cut specimenwith a thin flexible film deployed in a path of the RF cutting tool.

The present invention is also an intra-tissue therapeutic device,comprising a probe body, the probe body defining at least one internaldye lumen and a first window near a distal tip of the probe body, and atissue-marking tool configured to selectively bow out of and back intothe first window, the tissue-marking tool defining at least one dye portin fluid communication with the at least one dye lumen.

The device may further include one or more dye reservoirs in fluidcommunication with one or more dye lumens internal to the probe body.The dye reservoirs may be disposed within the probe body or externalthereto. The probe body further may include a tissue-cutting tool. Thetissue-cutting tool may be configured to selectively bow out and backinto the probe body and the tissue-marking tool may be configured tofollow in a path of the tissue-cutting tool as the device is rotated.The tissue-cutting tool may bow out and back into the first window. Theprobe body may define a second window near the distal tip thereof andthe cutting-tool may be configured to selectively bow out of and backinto the second window. The distal tip may define a distal dye port, thedistal dye port being in fluid communication with the internal lumen(s).The devices disclosed herein may be configured for a single use and maybe disposable. The dye reservoir(s) may be pre-loaded with a dye, suchas, for example, Methylene Blue, Congo Red and/or Lymphazurin® Blue. Thecutting tool may include an RF cutting tool and may further include adistal RF tissue-cutting tool disposed in the distal tip of the probebody.

A specimen isolator may be coupled to the tissue-marking tool, thespecimen isolator being adapted to isolate the specimen from tissuesurrounding the specimen. The specimen isolator may include a thinflexible film of material, one end thereof being attached to the probebody and another end thereof being attached to the tissue-marking tool.The material of the tissue isolator may be selected from a groupincluding a polyorganosiloxane, a polydiorganosiloxane, an inorganicelastomer, a silicone elastomer, a teraphthalate, a tetrafluoroethylene,a polytetrafluoroethylene, a polyimid, a polyester, Kevlar® and/or M5®,for example. The specimen isolator may be configured to extend radiallyfrom the probe body out of the window when the tissue-marking tool isbowed.

The present invention is also an intra-tissue therapeutic device,comprising a probe body, the probe body defining an internal tool lumenthat emerges from the probe body at a tool port defined near a distaltip of the probe body; a tool actuator, and a tissue specimenstabilization tool mechanically coupled to the tool actuator, thestabilization tool including a barbed tip adapted to selectively slidewithin the tool lumen and extend out of the tool port to penetrate andstabilize tissue adjacent the tool port.

The internal tool lumen may be generally parallel to a longitudinal axisof the probe body near a proximal end thereof and the internal toollumen may then curve away from the axis near the distal tip of the probebody to emerge at the tool port. A cutting tool may be disposed near thetip of the probe body. The cutting tool may include an RF cuttingelement that selectively bows out of and back into a window defined inthe probe body, the RF cutting element being adapted to cut a volume ofrevolution of tissue as the probe body is rotated inside a patient'ssoft tissue. The barbed tip may be configured to expand when emergingfrom the tool port. The device may be configured for a single use andmay be disposable.

The present invention may also be viewed as a soft tissue intra-tissuetherapeutic device, comprising a cutting tool adapted to cut a specimenfrom surrounding tissue; a tissue-marking tool adapted to mark thespecimen, at least a portion of the marking tool being mechanicallycoupled to the cutting means, and a tissue isolator, the tissueisolation means being adapted to expand radially form the device andisolate the cut specimen from the surrounding tissue as the device maybe rotated.

The cutting tool may include a radio frequency (RF) cutting tool. The RFcutting tool may include a distal RF cutting tool disposed at a distaltip of the device. The RF cutting tool may be configured to selectivelybow out of and back into a body of the device to cut a volume ofrevolution of tissue as the device is rotated inside within the tissue.The tissue-marking tool may also be configured to deliver dye to aselected portion of a surface of the cut specimen. The tissue-markingtool may be configured to selectively bow out of and back into a body ofthe device and to follow a path of the cutting tool as the device may berotated. The tissue isolator may include a thin flexible film ofmaterial, one end of the film being attached to a body of the device andanother end thereof being attached to the tissue-marking tool. Means fordelivering a pharmaceutical agent to the surrounding tissue may also beincluded, as may means for suctioning smoke, blood and/or bodily fluids.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a top view of a tissue-marking device according to anembodiment of the present invention.

FIG. 2 shows the tissue-marking device of FIG. 1 in a first deployedconfiguration.

FIG. 3 shows the tissue-marking device of FIG. 1 in a second deployedconfiguration.

FIG. 4 shows a front view of the tissue-marking device of FIG. 1, toillustrate the operation of the tissue-marking probe.

FIG. 5A shows another embodiment of the present invention, in which anintra-tissue probe includes integrated specimen cutting, marking andisolation tools.

FIG. 5B shows a cross-section of the intra-tissue probe of FIG. 5A,taken along lines AA′.

FIG. 6A shows the intra-tissue probe of FIG. 5A, in which the specimencutting, marking and isolation tools are shown in a deployedconfiguration.

FIG. 6B shows a cross section of the intra-tissue probe of FIG. 6A,taken along lines BB′.

FIG. 7 shows an intra tissue probe for cutting and marking tissuespecimens, according to another embodiment of the present invention.

FIG. 8 shows the probe of FIG. 7, in a first extended configuration.

FIG. 9 shows the probe of FIG. 7, in a second extended configuration.

FIG. 10A is a flowchart of a tissue-marking method according to anembodiment of the present invention.

FIG. 10B is a flowchart of a tissue-marking method according to anotherembodiment of the present invention.

FIG. 11 is a representation of a coagulation-marked tissue specimen,according to an embodiment of the present invention.

FIG. 12 is a representation of the marked tissue specimen of FIG. 11,viewed from another orientation.

FIG. 13 is a representation of the marked tissue specimen of FIG. 11,viewed from another orientation.

FIG. 14 is a representation of the marked tissue specimen of FIG. 11,viewed from another orientation.

FIG. 15 is a representation of a dye-marked tissue specimen, accordingto another embodiment of the present invention.

FIG. 16 is a representation of the marked tissue specimen of FIG. 15,viewed from another orientation.

FIG. 17 is a representation of the marked tissue specimen of FIG. 15,viewed from another orientation.

FIG. 18 is a representation of the marked tissue specimen of FIG. 15,viewed from another orientation.

FIG. 19 shows a tissue specimen-stabilizing device, according to anembodiment of the present invention.

FIG. 20 shows the tissue specimen-stabilizing device of FIG. 19, inwhich the tissue stabilization tool is shown in a deployedconfiguration.

FIG. 21 shows a partial top view of the device of FIGS. 19 and 20.

FIG. 22 shows another example of the distal barbed tip of the tissuespecimen stabilization tool of FIGS. 19-21.

DESCRIPTION OF THE INVENTION

FIG. 1 shows a top view of a tissue-marking device according to anembodiment of the present invention. The tissue-marking device 100includes a proximal portion 102 and a distal tip 104. The proximalportion 102 may include a marking tool actuator 118 and the distal tip104 may include a tissue-marking tool 106, which may include a thinflexible hollow ribbon or a thin flexible tube. The marking tool 106 maybe configured to selectively bow out of and to retract within a window110 defined within the body of the probe 100 when the marking toolactuator 118 is activated.

The tissue-marking probe 100 may also include an internal guide 112 (ormay define an internal lumen) to enable the marking tool 106 to slidewithin the removable cutting probe 100 when marking tool actuator 118 isactivated. The marking tool actuator 118 is shown as a thumb-activateddial in FIGS. 1-3 and 7-9. However, any other means of advancing andretracting the marking tool 106 may also advantageously be used withinthe context of the present invention. The tissue-marking probe 100 mayfurther include a window slide 108 disposed within the window 110. Theproximal end 102 of the probe 100 may further include window slideextending means 116. The window slide 108 is mechanically coupled to thewindow slide extending means 116 and is guided within the tissue-markingprobe 100 by an internal guide or lumen 114 defined along the length ofthe probe 100. According to the present invention, the window slide 108is configured to selectively cover a portion of the window 110 when thewindow slide extending means 116 are activated. Functionally, the windowslide 108 covers a portion of the window 110 to selectively vary thesize of the window 110 through which the tissue-marking tool 106 isallowed to extend or bow.

FIG. 2 shows a side view of the tissue-marking 100 probe of FIG. 1. Asshown therein, the probe 100 is in a configuration wherein thetissue-marking tool 106 is in a bowed or extended state. As shown at146, the body of the probe 100 may internally define at least oneinternal dye lumen 146 that is in fluid communication with a dyereservoir 140, which may be external to the probe 100 as shown in FIG. 1or internal thereto, as shown in FIGS. 2 and 3. The dye reservoir 140 isadapted to contain a volume of at least one dye. The dye reservoir 140is in fluid communication with the internal dye lumen 146, so as todeliver dye from the dye reservoir 140 to the tissue-marking tool 106.As shown, the tissue-marking tool 106 defines at least one dye port 142.Each of the dye ports 142 is in fluid communication with the dyelumen(s) 146 defined within the probe 100. A marking actuator 154controls the flow of dye from the dye reservoir 140 to the dye ports142. The marking actuator 154 may include a simple on/off valve toselectively open and cut the flow of dye to the dye ports 142.Alternatively, the marking actuator 154 may be pressure sensitive, so asto allow the physician to manually vary the flow of dye through theports 142 by varying the pressure applied to the marking actuator 154.The probe 100 may also define a distal dye extrusion port 144 in fluidcommunication with the internal lumen 146 and the dye reservoir 140(through a tributary lumen 147 defined within the probe body, forexample).

FIG. 3 shows the probe 100 of FIG. 2 in a configuration wherein thewindow slide 108 is slid over a greater portion of the window 110 thanis the window slide 108 of FIG. 2. In so doing, the window slide 108effectively decreases the size (shortens the length) of the window 110from which the tissue-marking tool 106 may bow or extend. Carefullychoosing the extend to which the window slide 108 covers the window 110allows precise control over the shape of the tissue-marking tool 106 asit bows or extends from the window 110. In turn, precise control overthe shape of the tissue-marking tool 106 as it bows out from the window110 allows the physician to precisely control the manner in which thetissue specimen is marked, as the tissue-marking tool 106 is caused toclosely conform to the shape and size of the cut specimen.

FIG. 4 shows a front view of the probe 100 of FIGS. 1, 2 and 3 andillustrates the operation of the tissue-marking probe 100. As showntherein, the probe 100 is inserted into the patient's tissue, preferablyfollowing the insertion track of the excisional device that cut thespecimen (shown at 150 in FIG. 4) from the surrounding tissue. Suitableexcisional devices are disclosed, for example, in commonly assigned U.S.Pat. No. 6,022,362, the disclosure of which is incorporated herein byreference in their entireties. Alternatively, a split introducer (notshown) may be used to insert the probe 100 into the patient's softtissue. The probe 100 is then navigated so that the window 110 isadjacent the cut specimen 150 to be marked. While rotating the probebody, in a clockwise direction (for example) as shown by the arrow 152,the tissue-marking tool 106 is extended radially out from the window 110so as to encompass the previously cut specimen 150. Using the markingactuator 154, the physician causes dye 148 to extrude or spray out ofthe dye extrusion ports 142 and onto the cut specimen 150. The flow ofdye 148 may be selectively cut on and off on different surfaces of thecut specimen 150 as the probe is rotated, so as to appropriately markthe orientation of the specimen 150 within the surrounding tissue. Forexample, the physician may mark (apply dye to) a left superior portionof the surface of the specimen 150, a right inferior portion thereof andthe distal end of the specimen 150 (using the distal dye port 144, forexample). In this manner, the physician may readily reconstruct theorientation of the specimen within the cavity created by the excision ofthe specimen 150.

As shown in FIGS. 5A, 5B, 6A and 6B, the tissue specimen, according tothe present invention, may be simultaneously cut, marked and isolatedfrom the surrounding tissue, all prior to retraction thereof from thepatient. As shown in FIG. 5, the probe 500 may include a specimenisolator 512 attached to the tissue-marking tool 514. According to thepresent invention, the specimen isolator 512 is adapted to isolate thespecimen from the surrounding tissue, as soon as the specimen is cut bythe tissue-cutting tool 508. According to the present invention, thetissue-cutting tool 508 may include an RF blade or wire and may be amonopolar or bipolar RF cutting blade or wire. Additionally, the probe500 may include a distal RF tissue-cutting tool 562 disposed in thedistal tip 504 of the probe body 560. The tissue-cutting tool 508 may beconfigured to selectively bow out of and back into the same window 510as the tissue-marking tool 514 bows out of and back into (as shown inFIGS. 5 and 6) or may be configured to bow out of and back into aseparate window (not shown) defined within the body of the probe 500.

According to an embodiment of the present invention, the specimenisolator 512 may include a thin flexible film of material. One end ofthe film may be attached to the body 560 of the probe 500 and anotherend of the film may be attached to the tissue-marking tool 514. Thespecimen isolator 512, in this manner, is configured to extend radiallyfrom the probe body 560 out of the window 510 when and as thetissue-marking tool 514 is bowed. When the tissue-cutting tool 508 andthe assembly including the tissue-marking tool 514 and the specimenisolator 512 are actuated by the same tool actuator 546, the probe 500may cut and isolate the soft tissue specimen from the surrounding tissuewith ease.

The tissue isolator 512, according to an embodiment of the presentinvention, may initially be stowed in a flattened configuration (bestshown in FIG. 5B) in a recessed portion 558 defined within the body 560of the probe 500. A weak and biologically inert adhesive may be usedkeep the specimen isolator 512 in its initially flattened state prior todeployment of the marking tool 514 within the patient's tissue. As themarking tool 514 is bowed out of the window 510 defined in the probebody 560, the specimen isolator 512 attached thereto unfolds from therecessed portion 558 and at least partially encapsulates the specimen asit is cut, as shown at FIG. 5B. Alternatively, the cutting tool 508 maybe deployed independently of the tissue-marking tool 514—specimenisolator 512 combination. In that case, a complete cut of the specimenmay be made within the patient prior to a subsequent tissue isolationand marking operation by an also independently actuated tissue-markingtool 514 and specimen isolator 512. One or more guides or internallumens 556 may be defined within the probe body 560 to guide thetissue-marking tool 514 and/or the tissue-cutting tool 580. As thetissue-marking and cutting tools 514, 508 are constrained in their pathalong the length of the probe 500 and attached at their distal ends toor near the distal tip 504 of the probe 500, when the tools 514, 508 arepushed in the distal direction, they tend to bow out of the window 510,which provides the only outlet for such bowing.

Functionally, when the probe 500 is inserted into soft tissue androtated (in the direction of arrows 516, for example), the cutting tool508 may be caused to bow out of and to extend outwardly from the window510 when actuated by the tool actuator 546 and caused to cut tissuecoming into contact therewith. As the probe 500 rotates and cuts, thespecimen isolator and the tissue-marking tool 514 may also becorrespondingly deployed by the same (or a separate) tool actuator 546and caused to precisely follow the trailing edge of the cutting tool 508(thereby following in its path) as it cuts the soft tissue. During thecutting and specimen isolation procedure, the marking actuator 554 maybe selectively actuated by the physician to mark the tissue specimenwith dye from the dye extrusion ports 542 as it is being isolated. Theprobe 500 may also advantageously include a distal dye port 544 to markthe distal end of the specimen. As with the embodiments shown in FIGS.1-3, a dye reservoir 140 may be disposed within the proximal end of theprobe 500 or may be disposed external thereto. A suitable biologicallyinert propellant may also be present in the dye reservoir 140 to insurethat the dye is appropriately sprayed onto the specimen to be marked.Suitable propellants include, for example, carbon dioxide and XXX.Several dye reservoirs 140 may be used to spray dyes of different colorsonto the specimen. In that case, each color of dye may be delivered toall or selected ones of the dye ports 142 through a separate lumendefined within the probe body 560.

After the cutting, marking and/or isolating procedures are concluded,the probe 500 may then be safely retracted from the patient's softtissue (such as the breast, for example). As the cut specimen isphysically isolated from the remaining tissue mass, the probability ofseeding the surrounding tissue with potentially abnormal cells ismarkedly decreased. This probability is also further decreased, as theprobe 500 according to the present invention allows the surgeon toobtain adequate margins of healthy tissue surrounding the target lesionby choosing the degree of bowing and extension of the cutting tool 508under (external or intra-tissue ultrasonic guidance, for example). Inthis manner, the integrity of the lesion itself is not violated, therebymaintaining tissue architecture intact.

As the tissue isolator 512 is preferably formed of a thin and flexiblefilm, it is able to lay substantially flat against the outer surface ofthe probe body 500 or within a slightly recessed portion 558 of theprobe body 500. The tissue isolator 512, therefore, offers littleadditional drag and resistance to the probe 500 as it is inserted intothe incision made in the patient's skin during or prior to theprocedure.

The material for the tissue isolator 512 may be a flexible semi-porousor non-porous material. For example, the tissue isolator may include asynthetic polymer such as a polyorganosiloxane or apolydiorganosiloxane. The material may include an inorganic elastomer,such as a silicone elastomer. The tissue isolator may also include ateraphthalate (PET), a tetrafluoroethylene (TFE) and/or or apolytetrafluoroethylene (PTFE). The tissue isolator may have a laminatestructure and may include one or more reinforcing layers including, forexample, a polyimid, a polyester, Kevlar(R) and/or a polymer such as theM5 fiber manufactured by Magellan Systems International of Arnhem, TheNetherlands, for example. Preferably, the tissue isolator will have ahigh tensile strength (over 1,000 psi) and a high tear resistance.Moreover, the material selected for the tissue isolator will be able towithstand temperatures in excess of about 180 C., for example. However,the tissue isolator 512 may be formed of a material other thanspecifically enumerated herein while remaining within the spirit of thepresent invention. Preferably, the shape and size of the tissue isolator512 are such as to minimize drag on the probe 500 as it is inserted androtated into the tissue.

FIGS. 7-9 show an intra-tissue probe 700, according to anotherembodiment of the present invention. The description of the structurescorresponding to reference numbers 102, 118, 116, 114, 112, 108, 110 and104 is presented above with respect to FIGS. 1-3 and is incorporatedherein by reference. Reference numeral 524 corresponds to an RF cuttingtool (either monopolar or bipolar) that is configured to selectively bowout of and back into the window 110 defined within the probe 700. Theprobe cutting tool 524 is electrically coupled to an RF power source 126such as are known in the art. The probe 700 may be utilized alone, or incombination with a specimen isolator, such as shown at 512 in FIGS. 5Athrough 6B. According to the present invention, a specimen may be markedas it is being cut or after a partial or complete cut has been made bythe tissue-cutting tool 524. Using an RF probe, such as shown at FIGS.7-9, a soft tissue excisional method, according to the presentinvention, includes a step of disposing a probe (such as shown at 700)within tissue from which a tissue specimen is to be taken, the probe 700including an RF tissue cutting tool (such as shown at 524) configured toselectively bow out of and back into a window 110 defined near a distaltip of the probe 700. The probe 700 may then be rotated while RF energyis applied to the RF cutting tool 524. The cutting tool 524 may then beselectively bowed out of the window 110 to cut the specimen from thetissue while the probe 700 is rotated. Selected portions of the surfaceof the specimen may then be selectively coagulated by the RF cuttingtool 524. By judiciously choosing the portions of the surface of thespecimen that are coagulated (and/or cauterized), the orientation of thespecimen within the body is may be reconstructed after the cut specimenis excised from the body, even if the cut specimen is twisted and/ordeformed during retraction thereof from the patient or during subsequenthandling. The cutting and marking described above may also be combinedwith tissue isolation as described relative to FIGS. 5A through 6Band/or with other tissue isolation structures and techniques. As shownin FIG. 9, the body of the probe 700 (and/or the respective probes shownin FIGS. 1-6B) may also define a plurality of through holes 138 in fluidcommunication with an internal lumen 140 defined within the probe 700.In turn, the internal lumen 140 may be in fluid communication with aproximal port 142 disposed at the proximal end 102 of the probe 700. Thethrough holes 138 may be utilized for the delivery of a fluid to thepatient during the cutting, isolating or marking procedure, such asantibiotic agents, analgesic agents or most any pharmaceutical agent.Such agents may be administered to the patient from the port 142.Alternatively, the port 142 may be coupled to suction and the throughholes 138 may be utilized to suction out the excisional site of smoke,blood or other bodily fluids during or after the excisional procedure.Alternatively still, more than one port 142 may be provided in theproximal portion 102 and more than one lumen 140 may be defined alongthe length of the probe 700. The additional lumen may be in fluidcommunication with selected through holes 138. By this structure, bothdelivery of a pharmaceutical agent and suctioning may be provided withina single probe 700.

FIGS. 10A and 10B are flowcharts of the excisional, marking and tissueisolation methods according to embodiments of the present invention.Turning first to FIG. 10A, step S10A1 calls for a probe, such as shownin FIGS. 1 through 6B, to be inserted into the patient's soft tissue.For example, a probe such as described herein may be inserted intobreast tissue. As shown at S10A2, the probe is then rotated. If thespecimen is not already cut from the main tissue mass in which the probeis inserted, a tissue-cutting tool (such as shown at 508 or 524) may beactivated and a complete or partial cut of the specimen may be made.Step S10A3 calls for the tissue-marking tool (such as shown at 106 or514) to be deployed, so that the path taken by the tissue-marking tool106, 514 follows the path taken by the cutting tool 508, 524. Note thatthe specimen may be cut by a probe such as shown at 700, after which atissue-marking specific probe, such as shown at FIGS. 1-3, may beinserted into the soft tissue after retraction of the probe 700 hasfinished its cut and has been removed. Alternatively, a combinationprobe, such as shown at FIGS. 6A through 6B may be employed to cut, markand isolate the specimen. One or more dyes may be extruded from the dyeports 142 to mark the specimen either during the cutting thereof orafter the specimen is completely severed from the surrounding tissue.The specimen may be concurrently isolated using the specimen isolator512 attached to the probe body and the tissue-marking tool 514 or may beisolated after the specimen is completely cut. After the specimen iscut, marked and/or isolated, it may be removed from the patient, byretracting the probe from the excision site and form the patient, asshown at S10A4.

Turning now to FIG. 10B, other embodiments of the present invention callfor the insertion of a probe, such as shown at FIGS. 6A through 9 intotissue, as outlined at S10B1. In step S10B2, RF power may be applied tothe cutting tool (such as shown at 508, 524) and the cutting tooldeployed (i.e., bowed out of window 110) while the probe 500, 700 isrotated, as shown at S10B2. Concurrently, the tissue isolator 512 (ifpresent) may be deployed to isolate the cut tissue from the surroundingtissue. Selected portions of the surface of the partially of fully cutspecimen may then be marked by coagulating (or cauterizing) the selectedportions using the RF cutting tool 508, 524. The cut, marked andoptionally isolated specimen may then be removed from the excision siteand the patient by retracting the probe, as outlined in step S10B4.

FIGS. 11-14 each show a representation of a same coagulation-markedtissue specimen 800 in different orientations, according to anembodiment of the present invention. The tissue specimen 800 is shown asmarked using one of the probes according to the present invention, asshown in FIGS. 1-9. The tissue specimen 800 defines 6 surfaces: the leftsuperior surface LS best seen in FIG. 11, the right superior surface RSbest seen in FIG. 12, the left inferior surface LI best seen in FIG. 13,the right inferior surface RI best seen in FIG. 14, the proximal surfaceP and the distal surface D hidden in FIGS. 11-14. To reconstruct theorientation of the specimen 800, the physician, according to the presentinvention, may mark selected portions of the surface of the specimen800. Using an RF cutting tool 508, 524, for example, the RS surface ofthe specimen 800 may be marked by coagulating or cauterizing it, in adistinctive pattern such as, for example, two lines. Similarly, selectedportions of the LS surface of the specimen 800 may be coagulated orcauterized to create three coagulation or cauterization lines. Likewise,the LI surface thereof may be selectively coagulated or cauterized. Inthis manner, the original orientation of the specimen 800 may be readilyreconstructed, even after the specimen 800 is removed from the patient,twisted and/or otherwise deformed during a pathological examination, forexample. To create the lines of coagulation or cauterization shown inFIGS. 11-14, the RF power delivered to the portion of the surface of thecut specimen 800 by the RF cutting tool 508, 524 may be momentarilyincreased from the power normally applied thereto during the cuttingprocedure. Preferably however, the coagulating or cauterization iscarried out by momentarily maintaining the RF cutting tool 508, 524immobile or substantially immobile on the selected portion of thesurface of the specimen 800 while the RF power delivered to the RFcutting tool 508, 524 is maintained constant. It is to be noted that thepattern of coagulation or cauterization lines shown in FIGS. 11-14 isbut an illustrative example, and that other combinations of surfaces ofthe specimen 800 may be marked (or marked differently than shown inFIGS. 11-14), it being only necessary to distinctively mark a sufficientnumber of surfaces so as to enable a later reconstruction of theorientation of the specimen 800 within the excision cavity.

FIGS. 15-18 each show a representation of a same dye-marked tissuespecimen 900 in different orientations, according to an embodiment ofthe present invention. As shown therein, selected surfaces of thespecimen 900 are marked with a dye, using the marking tool 106 and 514and the distal port 144, 544 in FIGS. 1-6B. Using the probes 100, 500 ofthe present invention, dye may be applied to selected surfaces of thespecimen 900 so as to enable a ready reconstruction of the orientationthereof after the specimen 900 is removed from the patient. As shown inFIG. 15, the RS and LI surfaces of the specimen 900 may be marked withdye using the marking tool 106, 514. The D surface may be marked withthe distal dye port 144, 544. Marking three selected surfaces of thespecimen 900 may be sufficient to enable the physician to reconstructthe original orientation of the specimen 900, even of the specimen 900has been twisted, compressed and/or otherwise deformed after excisionthereof from the patient. The dye markings may be of the same ordifferent colors. For example, the dye applied by the marking tool 106,514 may include any biologically inert dye, such as Methylene Blue,Congo Red and/or Lymphazurin® Blue, for example. The dye may bedelivered at a selectable graduated rate to the surface of the specimen900. For example, the dye may be delivered darker to a first portion ofthe surface of the specimen 900 and delivered relatively lighter to asecond portion of the surface of the specimen 900. Arrows 152, 516 inFIGS. 15 and 17 show the direction of rotation of the tissue-markingtool 106, 514 as it sweeps over the specimen 900. As its sweeps over thesurface of the specimen 900 and applies dye to selected surfacesthereof, the dye may become smeared, as shown in FIGS. 15 and 17. Thedirection of such smearing may provide the physician with yet anotherindication of the original orientation of the specimen 900 within theexcision cavity within the patient. Dye-based markings andcoagulation-based markings may be advantageously combined. For example,selected surfaces of a specimen may be marked using coagulation orcauterization, while the distal surface of the specimen may be markedwith dye, using the distal dye port 144, 544. Other combinations arepossible, and all such combinations are deemed to fall within the scopeof the present invention.

FIGS. 19, 20 and 21 show another embodiment 1000 of the presentinvention, which allows the orientation of the specimen to be preservedduring extraction thereof from the patient. Reference numerals 102, 104,116, 118, 108 and 144 are structures that correspond to like numberedstructures in FIGS. 1-3. The description thereof is, therefore, notrepeated here explicitly, but is incorporated herewith by reference.FIGS. 19-21 show a probe 1000 that includes a probe body 1016, the probebody 1016 defining an internal tool lumen 1004 that emerges from theprobe body 1016 at a tool port 1010 defined near the distal tip 104 ofthe probe body 1016. A tool actuator 1002 may be disposed near theproximal end 102 of the probe 1000. The tool actuator 1002 ismechanically coupled to a tissue specimen stabilization tool 1008disposed within the internal tool lumen 1004. The stabilization tool1008 may include a barbed tip (such as shown at 1012 or 1014 in FIG. 22,for example). The stabilization tool 1008 is adapted to selectivelyslide within the tool lumen 1004 and extend out of the tool port 1010 topenetrate and stabilize tissue (such as a cut specimen 1014, forexample) adjacent the tool port 1010. As shown in FIGS. 19 and 20, theinternal tool lumen 1004 may be generally parallel to a longitudinalaxis of the probe body 1016 near the proximal end 102 thereof and maycurve away from the axis near the distal tip 104 of the probe body 1016to emerge at the tool port 1010. The probe 1000 may also include acutting tool 1006 (an RF cutting tool, for example) disposed near thedistal tip 104 of the probe body 1016. The barbed tip 1012 of thestabilization tool 1008 may be configured to expand when it emerges fromthe tool port 1010. Indeed, FIG. 19 shows the barbed tip 1012 of thestabilization tool 1008 in a folded configuration, whereas FIG. 20 showsthe barbed tip 1012 in a deployed configuration. In such a deployedconfiguration, the barbed tip 1012 hooks into and securely holds thespecimen 1014, much like a harpoon. The barbed tip 1012 of thestabilization tool may include or be formed of an elastic material, suchas a Nitinol® or similar super elastic alloys, for example. The barbedtip may emerge from the probe 1000 within a hole 1018 defined in thecutting tool 1006 as shown at FIG. 21 or may emerge therefrom adjacentthereto, for example. Other placements of the tool port 1010 are readilyenvisaged. The barbed tip 1012, 1014 of the stabilization tool 1008 maybe shaped as shown in FIGS. 19, 20 or 22. Other designs for the barbedtip 1012, 1014 will occur to those of skill in this art, and all suchalternative designs are deemed to fall within the scope of the presentinvention.

The probes and devices described herein are preferably configured for asingle use and are disposable. Alternatively, the probes and devicesdisclosed herein may be sterilizable and re-usable. Moreover, the probesand devices described herein may be used alone or in combination withother soft tissue excisional systems, such as described in commonlyassigned and co-pending application entitled “Excisional Biopsy DevicesAnd Methods” filed on May 4, 2000 and assigned Ser. No. 09/565,611, thedisclosure of which is also incorporated herein in its entirety. Whilethe present inventions are well suited to procedures on breast tissue,they are equally well suited to procedures on most any other softtissue, such as lung tissue, thyroid tissue, liver tissue and/or othertissues.

While the foregoing detailed description has described preferredembodiments of the present invention, it is to be understood that theabove description is illustrative only and not limiting of the disclosedinvention. Those of skill in this art will recognize other alternativeembodiments and all such embodiments are deemed to fall within the scopeof the present invention. Thus, the present invention should be limitedonly by the claims as set forth below.

What is claimed is:
 1. An intra-tissue therapeutic device, comprising: aprobe body, the probe body defining at least one internal dye lumen anda first window near a distal tip of the probe body; a tissue-markingtool configured to selectively bow out of and back into the firstwindow, the tissue-marking tool defining at least one dye port in fluidcommunication with the at least one dye lumen, and at least one dyereservoir in fluid communication with the at least one dye lumen.
 2. Thedevice of claim 1, wherein the at least one dye reservoir is disposedwithin the probe body.
 3. The device of claim 1, wherein the at leastone dye reservoir is external to the probe body.
 4. The device of claim1, wherein the at least one dye reservoir is pre-loaded with a dye. 5.The device of claim 4, wherein the dye includes at least one ofMethylene Blue, Congo Red and Lymphazurin Blue.
 6. The device of claim1, wherein the probe body further includes a tissue-cutting tool.
 7. Thedevice of claim 6, wherein the tissue-cutting tool is configured toselectively bow out and back into the probe body and wherein thetissue-marking tool is configured to follow in a path of thetissue-cutting tool as the device is rotated.
 8. The device of claim 7,wherein the tissue-cutting tool bows out and back into the first window.9. The device of claim 8, wherein the probe body defines a second windownear the distal tip thereof and wherein the cutting-tool is configuredto selectively bow out of and back into the second window.
 10. Thedevice of claim 6, wherein the cutting tool includes an RF cutting tool.11. The device of claim 1, wherein the distal tip defines a distal dyeport, the distal dye port being in fluid communication with the at leastone internal lumen.
 12. The device of claim 1, wherein the device isconfigured for a single use and is disposable.
 13. The device of claim1, further including a distal RF tissue-cutting tool disposed in thedistal tip of the probe body.
 14. The device of claim 1, furtherincluding a specimen isolator coupled to the tissue-marking tool, thespecimen isolator being adapted to isolate the specimen from tissuesurrounding the specimen.
 15. The device of claim 14, wherein thespecimen isolator includes a thin flexible film of material, one endthereof being attached to the probe body and another end thereof beingattached to the tissue-marking tool.
 16. The device of claim 15, whereinthe specimen isolator is configured to extend radially from the probebody out of the window when the tissue-marking tool is bowed.
 17. Thedevice of claim 15, wherein the material of the tissue isolator may beselected from a group including a polyorganosiloxane, apolydiorganosiloxane, an inorganic elastomer, a silicone elastomer, ateraphthalate, a tetrafluoroethylene, a polytetrafluoroethylene, apolyimid, a polyester, Kevlar® and/or M5®.